Clinical trial approvals are on hold in India for nearly two years with very few applications being cleared by the Drug Controller General of India and there is no indication when the normalcy will return. The situation is a result of growing criticism on the way trials were being conducted in India by certain pharma companies and contract research organisations for some years now. The office of DCGI has to, therefore, act with extreme caution while clearing applications for trials. That is what is happening now. Between July and August 2013, the DCGI had received as many as 1122 applications for clinical trials and of which the New Drug Committee approved 285 but the DCGI office cleared only 162. And the Supreme Court of India issued an order last October staying all the 162 approvals granted by DCGI for conducting trials. The order was passed by a bench headed by Justice R M Lodha on a petition filed by health activist group Swasthya Adhikar Manch alleging serious irregularities in conducting trials in the country. It seems that the Supreme Court is under the belief that the country does not have a right mechanism to monitor the clinical trials so as to protect thousands of subjects who undergo trials. This is clear from the observations the SC made when it said that uncontrolled clinical trial of drugs by multinational companies were creating havoc in the country and the regulatory authorities failed to stop these rackets. It is true that several hundreds of deaths had taken place during clinical trials mainly on account of the unethical practices indulged in pharmaceutical companies and CROs.
As per the latest figures available from the office of DCGI, only 25 applications for clinical trials have been approved in the first five months of 2014. The slow rate of clearance of applications for clinical trials can obviously affect the process of new drug approvals in the country. It is not surprising, therefore, that DCGI allowed only 7 new drugs for marketing in the country against 35 new drugs approved for marketing in 2013. Research based Indian pharmaceutical companies and their representative body, IPA, have already alerted the government that the research work has come to almost a standstill with the DCGI stand on clinical trial following directions from the Supreme Court. This is certainly an alarming situation for the Indian pharmaceutical industry as its growth is under threat with very few new drugs being approved for marketing. The Apex Court’s concern is based on a number of unethical trials conducted by some CROs and pharma companies in the past causing deaths and injuries to the people of this country. Such irresponsible practices should not have happened. But, after the SC's stand, the health ministry laid down some stringent safeguards and provisions to ensure that rights and safety of subjects in clinical trials are not compromised. These measures with proper legal backing and effective monitoring by DCGI should ensure fair conduct of clinical trials in the country. Instead of that, discouraging or outright denial of permission to conduct of trials in the country is not the solution to the problem.